Recipharm and Exela Pharma Forge Strategic Alliance to Boost U.S. Sterile Manufacturing with 100+ Million Units Capacity

Sterile manufacturing capability in the US with over 100 million readily-available units (including vials and Pre-Filled Syringes – PFS) Extensi...

October 04, 2024 | Friday | News
Oncocyte's GraftAssure™ Assay Adopted by Top U.S. and German Transplant Hospitals, Progresses Toward FDA Submission

GraftAssure™ research assay adopted by two research hospitals that are top-five-in-country by organ transplant volume Company clears first stage...

October 03, 2024 | Thursday | News
European Commission Approves Junshi Biosciences' Toripalimab for Two Key Cancer Indications

Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of nov...

September 25, 2024 | Wednesday | News
Nxera Pharma Secures Japanese Approval for QUVIVIQ™ to Treat Insomnia Based on Positive Phase 3 Trial Results

The approval of QUVIVIQ™, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data, including from a Phase 3...

September 24, 2024 | Tuesday | News
Takeda Receives Japanese Approval for FRUZAQLA® (Fruquintinib) in Metastatic Colorectal Cancer Treatment

— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer — &md...

September 24, 2024 | Tuesday | News
EMA's CHMP Recommends Approval of Intas Pharmaceuticals' HETRONIFLY® (Serplulimab) for Extensive-Stage Small Cell Lung Cancer

Intas Pharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive op...

September 23, 2024 | Monday | News
AbbVie’s Mirvetuximab Soravtansine Receives Positive CHMP Recommendation for Platinum-Resistant Ovarian Cancer Treatment in EU

AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommen...

September 23, 2024 | Monday | News
European Commission Poised to Authorize Omicron KP.2-Adapted COVID-19 Vaccine for Individuals Aged 6 Months and Older

Upon authorization by the European Commission (EC), the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and o...

September 23, 2024 | Monday | News
Novo Nordisk’s Wegovy® Receives Positive Opinion from EMA for Label Update Reflecting Reduced Heart Failure Symptoms

Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opin...

September 20, 2024 | Friday | News
Astellas Launches DIGITIVA™, a New Digital Health Solution for Heart Failure Management

New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -...

September 19, 2024 | Thursday | News
Vidac Pharma Secures Broad U.S. Patent for Pioneering Cancer Treatment Mode of Action

Vidac Pharma Holdings Plc., a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments,  announces that the U...

September 19, 2024 | Thursday | News
Novartis Announces FDA Approval of Kisqali® for Expanded Use in Early Breast Cancer, Doubling Eligible Patient Population

– Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromata...

September 18, 2024 | Wednesday | News
Valneva Seeks to Expand IXCHIQ® Chikungunya Vaccine Use to Adolescents in Europe and Canada

Valneva SE , a specialty vaccine company, announced the submission of label extension applications to the European Medicines Agency (EMA) and Hea...

September 18, 2024 | Wednesday | News
Nicox’s ZERVIATE® Approved for Ocular Itching in China, Set to Launch with Ocumension Therapeutics

Nicox’s partner, Ocumension Therapeutics, has received approval for ZERVIATE® for ocular itching in China ZERVIATE® launch in China wil...

September 18, 2024 | Wednesday | News

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